(62 days)
MiniLoad Syringe (K202432)
PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML.
No.
A syringe is a medical device used for injecting or withdrawing fluids, which are procedures, rather than being a therapeutic device that directly treats a condition or disease.
No
The device is described as facilitating injections or fluid withdrawal, which are therapeutic or procedural actions, not diagnostic ones. There is no mention of it being used to analyze or identify medical conditions.
No
The device description clearly outlines physical components (hollow barrel, plunger, slip tip/luer-lock ends) and the performance studies focus on physical and material properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to facilitate injections into or withdraw fluids from the body." This describes a device used for direct interaction with the body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a syringe for fluid injection and aspiration, which is a common medical device used for administering substances or collecting samples directly from a patient.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
- Reagents or other components typically associated with IVD tests
The device described is a standard medical syringe used for procedures like administering medication, drawing blood, or aspirating fluids. These are not considered in vitro diagnostic activities.
N/A
Intended Use / Indications for Use
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data are available in support of the substantial equivalence.
- Freedom from Extraneous Matter (ISO 7886-1)
- Lubricant Quantification (ISO 7886-1)
- Plunger Stop Detachment (ISO 7886-1)
- Barrel Flange to Plunger Distance (ISO 7886-1)
- Dead Space (ISO 7886-1)
- Freedom from leakage (ISO 7886-1)
- Piston operational force (ISO 7886-1)
- Plunger Fit (ISO 7886-1)
- Luer connector (ISO 80369-7)
- Biocompatibility [External communicating device Blood path indirect; limited (
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 13, 2021
OcuJect, LLC Rebecca Pine Official Correspondent 1441 Avocado Ave, Suite 204 Newport Beach, California 92660
Re: K212544
Trade/Device Name: MiniLoad Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: September 13, 2021 Received: September 15, 2021
Dear Rebecca Pine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Alans Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212544
Device Name MiniLoad Syringe
Indications for Use (Describe)
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K212544 510(k) Summary
SUBMITTER I.
OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660
Contact person: Rebecca K Pine Phone: (760) 809-5178 Fax: (760) 290.3216 Date prepared: October 13, 2021
II. DEVICE
Name of the device: MiniLoad® Syringe Common of usual name: Syringe Classification name: Syringe, Piston Regulatory Class: II Product Code: FMF Regulation: 21 CFR 880.5860
-
III. PREDICATE DEVICE MiniLoad Syringe (K202432)- primary predicate
PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)- reference device -
IV. DEVICE DESCRIPTION The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.
-
V. INDICATIONS FOR USE The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
-
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of the modified MiniLoad Syringe are highly analogous to the technological characteristics of the cleared MiniLoad Syringe (K202432).
The similarities and differences are illustrated in the table below:
4
Subject device | Primary Predicate | Comparison | ||
---|---|---|---|---|
MiniLoad Syringe | ||||
Syringe | MiniLoad Syringe | |||
(K202432) | ||||
Proprietary Name | MiniLoad Syringe | MiniLoad Syringe | ||
Product Code | FMF | FMF | ||
Indications | The MiniLoad | |||
Syringe is used to | ||||
facilitate injections | ||||
into or withdraw | ||||
fluids from the body | The MiniLoad | |||
Syringe is used to | ||||
facilitate injections | ||||
into or withdraw | ||||
fluids from the | ||||
body | SAME | |||
Intended Users | Clinicians | Clinicians | SAME | |
Principle of operation | Manual | |||
advancement and | ||||
withdrawal of the | ||||
plunger within the | ||||
barrel | Manual | |||
advancement and | ||||
withdrawal of the | ||||
plunger within the | ||||
barrel | SAME | |||
Device components | Syringe | |||
Barrel | ||||
Plunger | Syringe | |||
Barrel | ||||
Plunger | SAME | |||
Materials Barrel | Polypropylene | |||
BorMed HF840MO | ||||
Cas # 9300-07-0 | Polypropylene | |||
GM1600E | SAME | |||
Plunger | Polyethylene | |||
blue pigment | ||||
P83424 | Polyethylene | |||
blue pigment | ||||
P83424 | SAME | |||
Lubricant | Oleamide | Oleamide | SAME | |
Barrel Size Volume | (ml) | 1mL | 1mL | SAME |
Barrel length | ~ 85mm | ~ 85mm | SAME | |
Barrel outside | ||||
diameter | ~ 6.4mm | ~ 6.4mm | SAME | |
Barrel inside | ||||
diameter | ~ 4.6mm | ~ 4.6mm | SAME | |
Barrel color | Transparent | Transparent | SAME | |
Barrel printing | Black ink | Black ink | SAME | |
Plunger length | 93.4 mm | |||
85.3 mm | 93.4 mm | Difference | ||
#..1 | ||||
Plunger color | Blue | Blue | SAME | |
Graduation | Printed, ISO 7886-1 | |||
compliant | Printed, ISO 7886-1 | |||
compliant | SAME | |||
Tip type | Luer slip | |||
Luer lock | Luer slip | Difference | ||
#2 | ||||
Dead space | ||||
specification | $\leq$ 0.023mL with | |||
95% | ||||
confidence/95% | ||||
reliability | ISO 7886-1 | |||
compliant | Difference | |||
#3 | ||||
Sterilization method | EO | EO | SAME | |
SAL | 10-6 | 10-6 | SAME | |
Sterilization | ||||
Validation Standard | ISO 11135-1 | ISO 11135-1 | SAME | |
Subject device | Primary Predicate | Comparison | ||
MiniLoad Syringe | MiniLoad Syringe | |||
(K202432) | ||||
Syringe | ||||
Biocompatibility | ISO 10993-1 | |||
(Biological | ||||
Evaluation) | ISO 10993-1 | |||
(Biological | ||||
Evaluation) | SAME | |||
ISO 10993-4 | ISO 10993-4 | |||
(Hemocompatibilty) | (Hemocompatibilty) | |||
ISO 10993-5 | ||||
(cytotoxicity) | ISO 10993-5 | |||
(cytotoxicity) | ||||
ISO 10993-7 (EO | ||||
residuals) | ISO 10993-7 (EO | |||
residuals) | ||||
ISO 10993-10 ( | ||||
Sensitization) | ISO 10993-10 ( | |||
Sensitization) | ||||
ISO 10993-10 | ||||
(Irritation, | ||||
Acute Systemic | ||||
Toxicity (ISO | ||||
10993-11) | ISO 10993-10 | |||
(Irritation, | ||||
Acute Systemic | ||||
Toxicity (ISO | ||||
10993-11) | ||||
Materials Mediated | ||||
Pyrogenicity (ISO | ||||
10993-10) | Materials Mediated | |||
Pyrogenicity (ISO | ||||
10993-10) | ||||
Performance Data | ISO 7886-1 | |||
ISO 83069-7 |
5
Difference #1: The subject device has a shorter plunger length. Differences addressed through testing per ISO 7886-1:2017.
Difference #2: The subject device has a luer lock connector. Differences addressed through testing per ISO 80369-7.
Difference #3: Subject device has dead space specification of